Abstract
BackgroundMany studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension. So far, no study comparing intravenous (IA) with volatile-based neuroanaesthesia (VA) has been able to demonstrate major outcome differences nor a superiority of one of the two strategies in patients undergoing elective supratentorial neurosurgery. Therefore, current practice varies and includes the use of either volatile or intravenous anaesthetics in addition to narcotics. Actually the choice of the anaestesiological strategy depends only on the anaesthetists' preferences or institutional policies.This trial, named NeuroMorfeo, aims to assess the equivalence between volatile and intravenous anaesthetics for neurosurgical procedures.Methods/DesignNeuroMorfeo is a multicenter, randomized, open label, controlled trial, based on an equivalence design. Patients aged between 18 and 75 years, scheduled for elective craniotomy for supratentorial lesion without signs of intracranial hypertension, in good physical state (ASA I-III) and Glasgow Coma Scale (GCS) equal to 15, are randomly assigned to one of three anaesthesiological strategies (two VA arms, sevoflurane + fentanyl or sevoflurane + remifentanil, and one IA, propofol + remifentanil). The equivalence between intravenous and volatile-based neuroanaesthesia will be evaluated by comparing the intervals required to reach, after anaesthesia discontinuation, a modified Aldrete score ≥ 9 (primary end-point). Two statistical comparisons have been planned:1) sevoflurane + fentanyl vs. propofol + remifentanil;2) sevoflurane + remifentanil vs. propofol + remifentanil.Secondary end-points include: an assessment of neurovegetative stress based on (a) measurement of urinary catecholamines and plasma and urinary cortisol and (b) estimate of sympathetic/parasympathetic balance by power spectrum analyses of electrocardiographic tracings recorded during anaesthesia; intraoperative adverse events; evaluation of surgical field; postoperative adverse events; patient's satisfaction and analysis of costs.411 patients will be recruited in 14 Italian centers during an 18-month period.DiscussionWe presented the development phase of this anaesthesiological on-going trial. The recruitment started December 4th, 2007 and up to 4th, December 2008, 314 patients have been enrolled.
Highlights
Many studies have attempted to determine the "best" anaesthetic technique for neurosurgical procedures in patients without intracranial hypertension
Several studies have demonstrated that in patient with intracranial hypertension the best strategy is based on intravenous anaesthesia for its beneficial cerebral haemodynamic effects, for its "neuroprotective" role and for its action on cerebral metabolism [1]
In patients undergoing elective supratentorial neurosurgery, no study comparing intravenous with volatile-based neuroanaesthesia has been able to demonstrate neither major outcome differences nor a superiority of one of the two strategies [3,5]
Summary
Anaesthesia for neurosurgical procedures should ideally provide optimal surgical conditions while maintaining appropriate cerebral oxygen supply and stable systemic haemodynamics. The authors demonstrated no differences in intraoperative brain volume, emergence time, early postoperative cognitive abilities, or the incidences of postoperative shivering, pain, or nausea and vomiting Both intraoperative hypertensive and hypotensive episodes were more common in patients anaesthetized with propofol and remifentanil. In patients undergoing elective supratentorial neurosurgery, no study comparing intravenous with volatile-based neuroanaesthesia has been able to demonstrate neither major outcome differences nor a superiority of one of the two strategies [3,5]. Mean interval to obtain an Aldrete score ≥ 9 was 15 minutes in all three groups This prospective, randomized clinical study found that the three anaesthetics did not differ in intra- or postoperative haemodynamic stability or early postoperative recovery variables
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